Владимир Путин утвердил поправки в закон «Об обращении лекарственных средств», предусматривающего ускорение регистрации ряда лекарств, а также унифицирует правила обращения лекарственных средств с международными договорами Евразийского экономического союза. Документ уже опубликован на портале правовых актов.
Закон уточняет особенности ввода в оборот отдельных групп фармацевтических препаратов (высокотехнологичные, орфанные и лекарственные препараты для лечения высокозатратных нозологий).
Законом устанавливается возможность предоставления подробной информации Росздравнадзору о зарегистрированных лекарственных препаратах по запросу Минздрава для контроля со стороны государства.
Также упрощаются правила о предоставлении документов при введении препаратов в обращение. С 1 сентября 2025 года регистрировать лекарства будут онлайн через федеральную государственную информационную систему (ФГИС). Распространяется только на добросовестных субъектов, участвующих в обращении фармпрепаратов.
До 31 декабря 2025 года также должны быть приведены в соответствие нормам ЕАЭС правила регистрации и оборота лекарств. Препараты, уже в обороте, до 2025 года можно продавать без перерегистрации.
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